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Grading Adverse Events - National Institutes of Health
the applicable network standards for reporting abnormal pregnancy outcomes on the CRFs. Determining Severity Grade for Parameters between Grades If the severity of an AE could fall in either one of two grades (i.e., the severity of an AE could be either grade 2 or grade 3), sites should select the higher of the two grades. Laboratory Values
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Clinical Trial Application Submission Guidance
rsc.niaid.nih.govVersion 1.0, October 11, 2018 Effective Date – November 1, 2018 1 Clinical Trial Application Submission Guidance Purpose: The purpose of this guidance document is to outline DAIDS’ requirements regarding the submission of
Division of AIDS (DAIDS) Table for Grading the Severity of ...
rsc.niaid.nih.govGrading Adult and Pediatric AEs When a single parameter is not appropriate for grading an AE in both adult and pediatric populations, separate parameters with specified age ranges are provided. If no distinction between adult and pediatric populations has been made, the listed parameter should be used for grading an AE in both populations.
DEPO-PROVERA- medroxyprogesterone acetate injection ...
rsc.niaid.nih.gov14.3 Bone Mineral Density Changes in Adolescent Females (12–18 years of age) ... continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching ... anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids).
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